Transvaginal Access Apparatus and Methods

This patent application claims priority from U.S. Provisional Patent Application No. 63/357,021 filed on Jun. 30, 2022, and from U.S. Provisional Patent Application No. 63/428,746 filed on Nov. 30, 2022, both of which are incorporated herein by reference in their entirety.

The present invention relates to devices and methods for performing minimally invasive surgeries, and in particular to enabling transvaginal access for multiple surgical tools to surgical sites.

It is well established that there are benefits of minimally invasive surgery. Instruments for such surgery typically have a surgical end effector located at the distal end of an articulated surgical arm (preferably with minimum diameter) that is inserted through a small opening (e.g., body wall incision, natural orifice) to reach a surgical site. In some instances, surgical instruments are passed through a cannula and an endoscope can be used to provide images of the surgical site. In some instances, a trocar needle is used to make an incision, and the incision is dilated, to enable access by surgical end effectors to a surgical site in the body cavity.

Available equipment for supporting minimally invasive surgeries can comprise numerous and disparate elements, and methods for using them are often complicated and not streamlined for efficiency. The state of the art of the available equipment means, for example, that replacement of a surgical tool (or of a surgical arm) during an operation requires the surgeon to remove all tools and arms from the body cavity before introducing or reintroducing them, e.g., in order to maintain sterility and status of insufflated gas. This drawback is exacerbated by gas systems for insufflation and expulsion not being associated with individual cannular conduits. As another example, the design of available cannulas does not take into account other instruments that need to access the body cavity besides the robotic surgical arms. As another example, needles and dilators generally need to be used and then removed completely from the body cavity to make way for other equipment items and/or the surgical arms. There is a need for improved designs of access devices, e.g., transvaginal access devices, for improving and streamlining the processes.

According to embodiments disclosed herein, a device for accessing a body cavity through a natural orifice comprises a proximal base member and a plurality of conduits arranged to receive a corresponding plurality of surgical tools. The device further comprises, for each conduit: (i) a lumen shaped for passage therethrough of a surgical tool, the lumen having a proximal port and a distal opening, (ii) a gas port in fluid communication with the lumen and displaced distally from the proximal port, and (iii) a proximal sealing gasket seated in the lumen and adapted for selectively opening and closing, the gasket being displaced distally from the proximal port and proximally from the gas port so as to create a respective proximally-sealed distal gas volume in communication with the body cavity.

In some embodiments, at least one of the gas ports can be configured for insufflating therethrough a gas, from an external source of gas, into the body cavity, and/or at least one of the gas ports can be configured for expelling insufflated gas therethrough, and/or he respective proximally-sealed distal gas volumes of the plurality of conduits can combine to form, in combination with the body cavity, a closed gas volume.

In some embodiments, it can be that when a surgical tool is inserted into the body cavity through a respective conduit of the plurality of conduits, the distal gas volumes of both the respective conduit and at least one other conduit of the plurality of conduits remain proximally-sealed and in communication with the body cavity.

In some embodiments, it can be that when the plurality of surgical tools have passed through the respective lumens to access the body cavity, and a surgical tool of the plurality of surgical tools is withdrawn proximally from the body cavity and passes out of the respective lumen through the proximal port, the distal gas volumes of both the respective conduit and at least one other conduit of the plurality of conduits remain proximally-sealed and in communication with the body cavity.

In some embodiments, it can be that the closed gas volume includes an insufflated gas and remains closed when a surgical tool is inserted into the body cavity through a respective conduit of the plurality of conduits. In some embodiments, it can be that the closed gas volume includes an insufflated gas and remains closed when a surgical tool is removed from the body cavity and passes out of a respective lumen through the proximal port. In some embodiments, each of the lumens can be entirely surrounded by a corresponding conduit. In some embodiments, a respective longitudinal portion of one or more of the lumens can be surrounded by the proximal base member. In some embodiments, a respective longitudinal portion of one or more conduits of the plurality of conduits can be surrounded by the proximal base member.

In some embodiments, an assembly can comprise: (i) the device of any one of claimsto, (ii) for each respective gas port, a fluid conveyance in communication therewith and comprising a respective fluid valve, and (iii) a source of a gas for insufflation of the body cavity, arranged for insufflating the gas into the body cavity through at least one of the fluid conveyances. In some embodiments, at least one of the fluid conveyances can be arranged for expelling insufflated gas therethrough. In some embodiments, the respective proximally-sealed distal gas volumes of the plurality of conduits can combine to form, in combination with the body cavity, a closed gas volume that remains closed when a surgical tool is inserted into the body cavity through a respective conduit of the plurality of conduits. In some embodiments, the closed gas volume can remain closed when a surgical tool is removed from the body cavity and passes out of a respective lumen through the proximal port.

In some embodiments, the device can additionally comprise, for each conduit: a dilator, and an actuatable puncturing needle biased to a withdrawn position and arranged to pass through an aperture at a distal tip of the dilator. In some embodiments, the dilator can be configured for passage through the proximal sealing gasket, such that when the dilator is withdrawn proximally from the body cavity and passes out of the respective conduit through the proximal port, the distal gas volume of at least one other conduit of the plurality of conduits remains proximally-sealed and in communication with the body cavity. In some embodiments, it can be that the closed gas volume remains closed when the dilator is removed from the body cavity and passes out of a respective lumen through the proximal port.

In some embodiments, the biasing can be by a biasing element disposed within the conduit. In some embodiments, the puncturing needle can be arranged to be withdrawn together with the dilator. In some embodiments, the device can additionally comprise an actuation member arranged to actuate, simultaneously, the respective puncturing needles of the plurality of conduits. In some such embodiments, the actuation member can be configured for being withdrawn from the device together with the respective puncturing needles and the respective dilators of the plurality of conduits.

In some embodiments, the conduits can comprise respective tubes.

In some embodiments, the conduits can be distally beveled to form, in combination, a section of a dilator. In some embodiments, the device can additionally comprise an actuatable puncturing needle biased to a withdrawn position and arranged to pass through an aperture at a distal tip of the device. In some embodiments, the distal tip of the device is at least partly beveled to form a section of a dilator. In some embodiments, the biasing can be by one or more biasing elements disposed outside the conduits.

In some embodiments, the device can additionally comprise an actuation member arranged to actuate the puncturing needle by overcoming a mechanical resistance of the one or more biasing elements. In some embodiments, the device can additionally comprise an activation-prevention mechanism preventing actuation of the puncturing needle without an initial action that does not cause actuation. In some embodiments, the actuation member can be displaceable to expose the proximal ports for receiving the surgical tools.

In some embodiment, the access device may include a stopper member configured for preventing activation of the actuation mechanism. Specifically, the stopper member may be configured for physically blocking the actuation member from being moved into an actuated position. In accordance with a particular example, the access device can be configured to receive, at least partially, within the lumen, a piece including said stopper member preventing activation of the actuation member. In particular, the design may be such that said piece is configured for being introduced into the lumen in a step succeeding the step of activation of the puncturing needle, thereby rendering the puncturing needle deactivated for the remainder of a procedure.

In accordance with a specific example, said piece may be formed with an axial extension constituting the blocking member. The actuation member may have a drive path along which it transitions between an actuated and non-actuated positions. Correspondingly, the blocking member may be designed such that, once the piece is inserted into the lumen of the access device, the blocking member extends axially into a position crossing the drive path of the actuation member, thereby physically blocking it from transitioning into an activated position.

In addition, the extension may be designed in order to complement the design of the access device. Specifically, the extension may also constitute a portion of a fitting mechanism, configured for retaining the inserted piece within the lumen and/or attached to the access device. Thus, the extension member may have a dual purpose—both fixing the position of the piece with respect to the access device, and, at the same time, preventing the actuation member from being activated.

It should be noted that spontaneous activation of the actuation mechanism may result in the puncturing needle being activated, which, if done in an unsupervised manner, may cause damage to tissue. The solution provided by the subject matter of the present application elegantly restricts this possibility by introducing the blocking member in a step superseding the activation of the puncturing needle.

In some embodiments, the plurality of conduits can comprise exactly two conduits.

According to embodiments disclosed herein, a device for accessing a body cavity through a natural orifice comprises a proximal base member and a plurality of conduits arranged to receive a corresponding plurality of surgical tools. The device further comprises, for each conduit: (i) a lumen shaped for passage therethrough of a surgical tool, the lumen having a proximal port and a distal opening, (ii) a gas port in fluid communication with the lumen and displaced distally from the proximal port, and (iii) a proximal sealing gasket seated in the lumen and adapted for selectively opening and closing, the gasket being displaced distally from the proximal port and proximally from the gas port so as to create a respective proximally-sealed distal gas volume in communication with the body cavity, the respective proximally-sealed distal gas volumes of the plurality of conduits combining to form, in combination with the body cavity, a closed gas volume, wherein the closed gas volume is effective to remain closed when any one or more of the following events occur: (i) a surgical tool is inserted into the body cavity through a respective conduit of the plurality of conduits, and (ii) a surgical tool is removed from the body cavity and passes out of a respective lumen through the proximal port.

In some embodiments, it can be that when the closed gas volume includes an insufflated gas, the closed gas volume is effective to remain closed when any one or more of the following events occur: (i) a surgical tool is inserted into the body cavity through a respective conduit of the plurality of conduits, and (ii) a surgical tool is removed from the body cavity and passes out of a respective lumen through the proximal port.

In some embodiments, it can be that at least one of the gas ports is configured for insufflating therethrough a gas, from an external source of gas, into the closed gas volume, and/or that at least one of the gas ports is configured for expelling insufflated gas therethrough. In some embodiments, in can be that when (i) the closed gas volume includes an insufflated gas, (ii) a surgical tool is removed from the body cavity and passes out of a respective lumen through the proximal port, and (iii) subsequent to the removal, a replacement surgical tool is inserted into the body cavity through the respective lumen, the closed gas volume is effective to retain substantially all of the insufflated gas.

According to embodiments disclosed herein, a device for accessing a body cavity through a natural orifice comprises: (a) a proximal base member; (b) a plurality of conduits arranged to receive a corresponding plurality of surgical tools for passage therethrough to the body cavity, the conduits distally beveled to form, in combination, a section of a dilator; (c) an actuatable puncturing needle biased to a withdrawn position by one or more biasing elements disposed outside the conduits and arranged to pass through an aperture at a distal tip of the device; and (d) an actuation member arranged to actuate the puncturing needle by overcoming a mechanical resistance of the one or more biasing elements.

In some embodiments, it can be that when the actuation member is released after an actuation, the puncturing needle is configured to return to the withdrawn position for storage at least during a use of the dilator to distally advance the device. According to embodiments disclosed herein, it can be that when the actuation member is released after an actuation, the puncturing needle is configured to return to the withdrawn position for storage at least during passage of the surgical tools through the plurality of conduits to access the body cavity.

In some embodiments, the device can additionally comprise an actuation-prevention mechanism preventing actuation of the puncturing needle without an initial action that does not cause actuation. In some embodiments, the actuation member is displaceable to expose the proximal ports for receiving the surgical tools.

In some embodiments, it can bet that the device comprises exactly one actuatable puncturing needle and exactly one actuation member.

In some embodiments, the distal tip can be formed integrally with the plurality of conduits. In some embodiments, the plurality of conduits can be formed together and not be separable non-destructively.

In some embodiments, the plurality of conduits can comprise exactly two conduits.

In some embodiments, a transverse cross-section of the device intercepting the plurality of conduits at any point distal to the proximal base can be such that a minimum-area circumscription of the cross-section is concave.

In some embodiments, the device can further comprise, for each conduit: (i) a lumen shaped for passage therethrough of a surgical tool, the lumen having a proximal port and a distal opening, (ii) a gas port in fluid communication with the lumen and displaced distally from the proximal port, and/or (iii) a proximal sealing gasket seated in the lumen and adapted for selectively opening and closing. The gasket can be displaced distally from the proximal port and proximally from the gas port, e.g., so as to create a respective proximally-sealed distal gas volume in communication with the body cavity. At least one of the gas ports can be configured for insufflating therethrough a gas, from an external source of gas, into the body cavity. At least one of the gas ports can be configured for expelling insufflated gas therethrough.

In some embodiments, (i) the respective proximally-sealed distal gas volumes of the plurality of conduits can combine to form, in combination with the body cavity, a closed gas volume, and/or (ii) the closed gas volume can be effective to remain closed when a surgical tool is inserted into the body cavity through a respective conduit of the plurality of conduits.

In some embodiments, the respective proximally-sealed distal gas volumes of the plurality of conduits can combine to form, in combination with the body cavity, a closed gas volume, and the closed gas volume can be effective to remain closed when a surgical tool is removed from the body cavity and passes out of a respective lumen.

In some embodiments, the closed gas volume can include an insufflated gas and can remain closed when a surgical tool is inserted into the body cavity through a respective conduit of the plurality of conduits.

In some embodiments, the closed gas volume can include an insufflated gas and can remain closed when a surgical tool is removed from the body cavity and passes out of a respective lumen through the proximal port.

A method is disclosed, according to embodiments of the present invention, for accessing a surgical site in a body cavity with multiple surgical tools through a natural orifice. The method comprises: (a) providing an access device comprising a proximal base member and a plurality of conduits, and further comprising, for each conduit: (i) a lumen having a proximal port and a distal opening, (ii) a gas port in fluid communication with the lumen and displaced distally from the proximal port, and (iii) a proximal sealing gasket seated in the lumen and adapted for selectively opening and closing, the gasket being displaced distally from the proximal port and proximally from the gas port so as to create a respective proximally-sealed distal gas volume in communication with the body cavity; (b) inserting a distal portion of the access device through the orifice; and (c) introducing the multiple surgical tools into the body cavity through respective lumens of the access device.

In some embodiments, the proximally-sealed distal gas volumes can remain proximally-sealed and in communication with the body cavity during the introducing.

In some embodiments, the introducing can include introducing one surgical tool at a time. In some embodiments, the introducing can include introducing one or more of the multiple surgical tools in parallel.

In some embodiments, the method can additionally comprise, after the introducing of the multiple surgical tools, proximally withdrawing a surgical tool of the multiple surgical tools from the body cavity and out of the respective lumen via the proximal port. The proximally-sealed distal gas volumes can remain proximally-sealed and in communication with the body cavity.

In some embodiments, the surgical tools can comprise robotic tools, and the introducing of the surgical tools can include controlling the movements of the robotic tools.

In some embodiments, the method can additionally comprise: (i) placing an external gas source in communication with a respective gas port of the plurality of conduits via a fluid conveyance comprising a fluid valve, and/or (ii) insufflating a gas from the gas source into the body cavity. In some such embodiments, the method can additionally comprise expelling insufflated gas through a gas port of the plurality of conduits into a fluid conveyance comprising a fluid valve. In some embodiments, the method can additionally comprise: replacing a surgical tool when the closed gas volume includes an insufflated gas. The closed gas volume can be effective to remain closed when any one or more of the following events occur: (i) a surgical tool is introduced into the body cavity through a respective conduit of the plurality of conduits, and (ii) a surgical tool is removed from the body cavity and passes out of a respective lumen through the proximal port.

In some embodiments, the plurality of conduits can comprise exactly two conduits.

In some embodiments, the provided access device can include one or more previously used conduits.

In some embodiments, the access device can additionally comprise, for each conduit: a dilator, and an actuatable puncturing needle biased to a withdrawn position and arranged to pass through an aperture at a distal tip of the dilator. The biasing can be by a biasing element disposed within the conduit. In some embodiments, the method can additionally comprise: (i) actuating, simultaneously, the respective puncturing needles of the plurality of conduits, using an actuation member of the access device, (ii) forming an incision in tissue which separates the body cavity from the orifice, and/or (iii) dilating the incision by advancing the distal portion of the access device therethrough to place respective distal openings of the conduits in communication with the body cavity.

In some embodiments, the method can additionally comprise proximally withdrawing the respective dilators of the plurality of conduits from the body cavity, and/or causing the respective dilators to pass out of the conduits. The proximally-sealed distal gas volumes can remain proximally-sealed and in communication with the body cavity.

In some embodiments, the puncturing needles and the biasing elements can be withdrawn together and/or are withdrawable with the dilator. In some embodiments, the puncturing needles and actuation member(s) can be withdrawn together and/or are withdrawable with the dilator.

In some embodiments, the conduits can comprise respective tubes.

In some embodiments, the conduits can be distally beveled to form, in combination, a section of a dilator. In some embodiments, the access device can additionally comprise an actuatable puncturing needle that is biased, by one or more biasing elements disposed outside the conduits, to a withdrawn position and arranged to pass through an aperture at a distal tip of the device. The distal tip of the device can be at least partly beveled to form a section of a dilator.

In some embodiments, the method can additionally comprise: (i) actuating the puncturing needle using an actuation member arranged to overcome a mechanical resistance of the one or more biasing elements, (ii) forming an incision in tissue which separates the body cavity from the orifice, and/or (iii) dilating the incision by advancing the distal portion of the access device therethrough to place respective distal openings of the conduits in communication with the body cavity. In some embodiments, the access device can additionally comprise an activation-prevention mechanism preventing actuation of the puncturing needle without an initial action that does not cause actuation. In some embodiments, the actuation member can be displaceable to expose the proximal ports for receiving the surgical tools.

A method is disclosed, according to embodiments of the present invention, for accessing a surgical site in a body cavity with multiple surgical tools through a natural orifice. The method comprises: (a) providing an access device comprising: (i) a proximal base member, (ii) a plurality of conduits distally beveled to form, in combination, a section of a dilator, and (iii) a single actuatable puncturing needle disposed outside the conduits and biased to a withdrawn position by one or more biasing elements; (b) inserting, through the orifice, a distal portion of the access device; (c) actuating the puncturing needle using an actuation member arranged to overcome a mechanical resistance of the one or more biasing elements, wherein the actuating includes (i) passing a distal tip of the puncturing needle through an aperture at a distal tip of the device, and (ii) forming an incision in tissue which separates the body cavity from the orifice; (d) dilating the incision by distally advancing the access device therethrough to place respective distal openings of the conduits in communication with the body cavity; and (e) introducing the multiple surgical tools into the body cavity through respective conduits.